I think this is an important issue. is the FDA approval required or Not. Shredaholic says that because of the deaths, then the REGULATIONS call for re-approval from FDA.
Hope Maxdad, DrSayyed or Jagan can elaborate on this please. thanx
So it is NOT a Binary event any more..? We will have the news that Takeda updated and submitted the REMS? and then a waiting game until the FDA reply is made public...
What is REMS?
how long does it usually take?